MDCG 2021-27 Q&A on importers and distributors – sort of box of chocolates

Life, as they say, is like a box of chocolates: you never know what you’re going to get. MDCG guidance documents are very much like that too. Even if you’ve seen them coming in the consultation phase the end result may still surprise you. Some are really good, some are really good and complex, some […]


Food Information on Allergens: no escape!

Your company wants to provide bullet proof information on the food products it offers for sale in view of the upcoming changes in food legislation? This post may be helpful to you,…


E-labelling regulation published, no changes / big disappointment

Just before last weekend the final e-labelling regulation was published in the Official Journal of the EU, see right here. As you will see when you run a compare (like I did)…


EU regulation of e-labelling of medical devices to apply as of 1 March 2013

On 23 September 2011 the draft of the e-labelling regulation that I wrote about earlier was discussed in the comitology committee for the Medical Devices Directive. I received the text of the…


Multi-jurisdictional advertising of medical devices – UK, Netherlands and Germany

Advertising and promotion of medical devices are not harmonised under the EU medical devices directive, resulting in a fragmented legal landscape that differs from one EU member state to the other. To…


Dutch court allows e-labelling for medical devices

In a judgment of 20 September 2010 the The Hague District Court ruled that it was OK for AED that are CE marked to not be accompanied by paper instructions for use…

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